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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 30, 2019 No. 546

About accreditation of certification bodies and test laboratories (centers) performing assessment works (confirmation) of compliance concerning the defensive products (works, services) delivered according to the state defensive order and introduction of amendments to separate acts of the Government of the Russian Federation

According to part 4 of article 2 of the Federal law "About Accreditation in National Accreditation System" Government of the Russian Federation decides:

1. Approve enclosed:

Rules of accreditation of certification bodies and test laboratories (centers) performing assessment works (confirmation) of compliance concerning the defensive products (works, services) delivered according to the state defensive order (further - Rules of accreditation);

requirements imposed to the accreditation body performing accreditation of certification bodies and test laboratories (centers) performing assessment works (confirmation) of compliance concerning the defensive products (works, services) delivered according to the state defensive order;

changes which are made to acts of the Government of the Russian Federation.

2. To the Ministry of Industry and Trade of the Russian Federation:

a) in 3-month time in coordination with the Ministry of Defence of the Russian Federation, other interested state customers of the state defensive order and Federal Antimonopoly Service to approve regulations on carrying out tender by determination of the organization for implementation of functions of accreditation body according to Rules of accreditation;

b) in 3-month time from the date of implementation of the subitem "an" of this Item to hold competition by determination of the organization for implementation of functions of accreditation body according to Rules of accreditation and to introduce to the Government of the Russian Federation the draft of the act of the Government of the Russian Federation of investment of the winner of tender with powers on implementation of the specified functions;

c) in 9-month time according to Rules of accreditation to approve:

form of the certificate of accreditation of certification body of products (works, services) delivered according to the state defensive order (further - products), test laboratory (center), certification body of systems of quality management, including appendix to the certificate of accreditation, and the requirement to its registration;

the application form about accreditation of certification body of products, test laboratory (center), certification body of systems of quality management and the requirement to its registration;

the application form about expansion of area of accreditation of certification body of products, test laboratory (center), certification body of systems of quality management and the requirement to its registration;

the application form about reducing area of accreditation of certification body of products, test laboratory (center), certification body of systems of quality management and the requirement to its registration;

the application form about issue of the duplicate of the certificate of accreditation;

the application form about renewal of the certificate of accreditation and the requirement to its registration;

forms of statements for certification of the expert in accreditation, of renewal of the certificate on certification of the expert in accreditation, of issue of the duplicate of the certificate on certification of the expert in accreditation, of issue of the copy of the certificate on certification of the expert in accreditation, of early termination of action of the certificate on certification of the expert in accreditation and requirements to their registration;

the document form about the declared area of accreditation of certification body of products, test laboratory (center), certification body of systems of quality management and the requirement to its registration;

form of the certificate on certification of the expert in accreditation and requirements to its registration;

forms of the expert opinion by results of documentary examination and the act of exit assessment of the applicant (accredited person);

d) in 9-month time in coordination with the Ministry of Defence of the Russian Federation, other state customers of the state defensive order and Federal Antimonopoly Service to introduce in accordance with the established procedure in the Government of the Russian Federation drafts of the acts of the Government of the Russian Federation establishing according to Rules of accreditation:

accreditation criterions of certification bodies of products, test laboratories (centers), certification bodies of systems of quality management of the organizations performing activities for development, production, testing, installation, installation, maintenance, repair, utilization and realization of arms and military equipment, delivery of the components, raw materials and materials which are subject of deliveries within the accompanied transactions on the state defensive order, activities for development, production, realization, testing, utilization and storage of ammunition, and also the organizations performing development, production, testing, delivery as the head contractor of deliveries of products of electronic component base or the contractor participating in deliveries of products of electronic component base on the basis of requirements of international standards, national standards of the Russian Federation, the state military standards and also the documents accepted by the international organizations for accreditation and (or) the regional organizations for accreditation;

approximate terms of the contract about work on accreditation;

technique of determination of the amount of payment for implementation of procedures of accreditation, including determination of the amount of payment for conducting documentary examination and exit assessment of the applicant (accredited person), inspection check-up, the repeated assessment of accredited persons, assessment of effectiveness taken and the adjusting measures for results of inspection check-up realized by accredited person, for expansion of area of accreditation and carrying out certification of experts in accreditation;

list of areas of certification of experts in accreditation;

regulations on certifying commission of accreditation body;

list of areas of specialization of technical experts;

requirements to technical experts;

procedure for forming and maintaining the register of accredited bodies on certification of products, test laboratories (centers) and certification bodies of systems of quality management, the register of experts in accreditation, the register of technical experts, the register of the certificates of conformity of products issued by the accredited bodies on certification performing assessment works (confirmation) of compliance of products, the register of the certificates of conformity of systems of quality management issued by the accredited bodies on certification performing assessment works (confirmation) of compliance of systems of quality management and procedure for provision of the data containing in the specified registers;

procedure of monitoring of activities of accredited persons, accreditation experts and technical experts;

rules of forming, maintaining and storage of accreditation cases and certification cases;

procedure for provision of data on certificates of conformity of products, the certificates of conformity of systems of quality management issued by accredited bodies on certification and also about accredited persons and their activities;

procedure for evaluating competence of the physical persons applying for receipt of the status of the expert in accreditation;

procedure for recertification of experts in accreditation for new term;

regulations on the commission on appeals of accreditation body;

regulations on public council on accreditation;

regulations on technical committee on development of rules, requirements and procedures of accreditation;

requirements to the expert organizations for accreditation;

image of sign of accreditation and procedure for its application by accredited persons;

procedure for consideration of the claims to activities of accredited bodies for certification of products, test laboratories (centers) and certification bodies of systems of quality management which arrived in accreditation body.

3. Determine that the realization of Item 2 of this resolution is enabled by the Ministry of Industry and Trade of the Russian Federation within the powers determined by this resolution and the number of employees of central office of the Ministry, and also budgetary appropriations provided to the Ministry in the federal budget for the corresponding year on management and management in the sphere of the established functions established by the Government of the limiting Russian Federation.

4. Determine that:

certificates of accreditation of certification bodies and test laboratories (centers) performing assessment works (confirmation) of compliance of products, certificates of accreditation of the certification bodies performing works on certification of systems of quality management of the organizations performing development, production, testing, installation, installation, maintenance, repair, utilization and realization of arms and military equipment including components, raw materials and materials, and also development, production, realization, testing, utilization and storage of ammunition, and also the organizations performing development, production, testing, delivery as the head contractor of deliveries of products of electronic component base or the contractor participating in deliveries of products of electronic component base which are issued about day of entry into force of this resolution in one of systems of voluntary certification in the sphere of assessment (voluntary confirmation) concerning products and (or) systems of quality management and which effective period did not expire are applied to implementation of activities for assessment (confirmation) of compliance of products and (or) systems of quality management before the termination of term of their action, but no later than 24 months from the date of entry into force of this resolution;

certificates on certification of experts in accreditation which are granted about day of entry into force of this resolution in national accreditation system or in one of systems of voluntary certification in the sphere of assessment (voluntary confirmation) of compliance concerning products and (or) systems of quality management of the organizations specified in the paragraph the second this Item and which effective period did not expire are applied to implementation of activities for assessment (confirmation) of compliance of products and (or) systems of quality management before the termination of term of their action, but no later than 12 months from the date of entry into force of this resolution;

certificates of accreditation of certification bodies and test laboratories (centers) performing assessment works (confirmation) of compliance concerning products, certificates of accreditation of the certification bodies performing works on certification of systems of quality management and the certificates on certification of experts in accreditation granted from the date of entry into force of this resolution are not subject to application for implementation of activities for assessment (voluntary confirmation) of compliance of products and (or) systems of quality management of the organizations specified in paragraph one of this Item.

5. This resolution becomes effective after 12 months from the date of its official publication, except for the paragraph of third Item 1 and Items 2 - 4, becoming effective from the date of official publication of this resolution.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of April 30, 2019 No. 546

Rules
accreditations of certification bodies and test laboratories (centers) performing assessment works (confirmation) of compliance concerning the defensive products (works, services) delivered according to the state defensive order

I. General provisions

1. These rules govern the relations arising between participants of accreditation and other persons in communication:

a) with implementation of accreditation of certification bodies and test laboratories (centers) performing assessment works (confirmation) of compliance concerning the defensive products (works, services) delivered according to the state defensive order (further - products), regarding compliance to requirements of the state customer of the state defensive order (further - the state customer) if taking into account total risk of doubtful assessment of conformity of products (works, services) and harm during its creation and application (operation, storage, transportation, utilization) in peace time, and also technical complexity and the importance for needs of defense of the country and safety of the state assessment of conformity in the form of confirmation of conformity is provided in the public contract (agreement);

b) with implementation of accreditation of test laboratories (centers) entering into the specialized and expert organizations attracted by the state customers (customers), head contractors of deliveries of products according to the state defensive order (further - the head contractor), the contractor participating in deliveries of products according to the state defensive order (further - the contractor), for evaluating compliance of products, including products and their components, accessories, raw materials and materials, and also design processes (including researches), productions, constructions, installation, adjustment, operation, storage, transportation, realization, utilization and burial of the specified products (further - processes);

c) with implementation of accreditation of the certification bodies performing works on certification of systems of quality management of the organizations performing:

development, production, testing, installation, installation, maintenance, repair, utilization and realization of arms and military equipment, and also development, production, realization, testing, utilization and storage of ammunition;

development, production, testing, delivery as the head contractor of products of electronic component base or the contractor participating in deliveries of the specified products;

delivery of the components, raw materials and materials which are subject of deliveries within the accompanied transactions on the state defensive order;

d) with certification of experts in accreditation, selection of the technical experts and the expert organizations for accreditation attracted to performance of works on accreditation according to these rules;

e) with accomplishment of other works connected with accreditation of certification bodies and test laboratories (centers) according to these rules.

2. These rules do not govern the relation in the sphere of accreditation of certification bodies and test laboratories (centers) performing assessment works of compliance in part:

a) products applied for the purpose of protection of the data which are the state secret or carried to other information of limited access, and also other special equipment used in the sphere of safety of the state protected in accordance with the legislation of the Russian Federation;

b) products to which mandatory requirements are established by technical regulations;

c) products applied in the field of civil defense, protection of the population and the territories from emergency situations, ensuring fire safety and safety of people on water objects;

d) nuclear charges, nuclear ammunition and their components, and also the processes connected with their development, testing, production, dismantling and utilization;

e) military nuclear power plants, and also processes of their creation, maintenance and utilization.

3. The concepts applied in these rules mean the following:

a) "accreditation" - the confirmation of conformity of the applicant, accredited person to accreditation criterions which is the official certificate of his competence to perform activities in certain area of accreditation;

b) "accredited person" - the Russian legal entity irrespective of form of business accredited as certification body of products, test laboratory (center) or certification body of systems of quality management according to the procedure, established by these rules;

c) "certification of the expert in accreditation" - confirmation of conformity of the physical person applying for receipt of the status of the expert in accreditation to the requirements established by these rules and recognition of his competence when evaluating compliance of the applicant (accredited person) to accreditation criterions of certain area of certification;

d) "appeal" - the appeal of the applicant, accredited person, applicant, accreditation expert to accreditation body about review of its decision made according to the established powers;

e) "the certificate of accreditation" - the document issued by accreditation body to accredited person and certifying accreditation in certain area of accreditation;

e) "audit" - process of independent receipt of data and information, including their documentation and assessment, for the purpose of establishment of extent of fulfillment of requirements to which there shall correspond the quality management system of the organizations specified in the subitem "v" of Item 1 of these rules and procedures of certification;

g) "exit assessment" - set of the actions for assessment of conformity of the applicant and accredited person to accreditation criterions held by expert group of accreditation body on the place (places) of implementation of activities in certain area of accreditation;

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